An individual bioequivalence criterion: regulatory considerations.

  title={An individual bioequivalence criterion: regulatory considerations.},
  author={Mei-Ling Chen and Rabindra Patnaik and Walter W. Hauck and Donald J. Schuirmann and Terry Hyslop and Roger Williams},
  journal={Statistics in medicine},
  volume={19 20},
Over the years, concerns have been raised regarding the appropriateness of using the average bioequivalence approach for evaluation of comparability between formulations. In lieu of average bioequivalence, scientists from academia, industry and regulatory agencies have spent considerable effort and time in exploring the concepts of population and individual bioequivalence, and developing the statistical methods to assess the bioavailability metrics using these approaches. Recently, the Food and… CONTINUE READING